Criteria and Potential Predictors of Severity in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Criteria and Potential Predictors of Severity in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218265
• Other study ID #: 9229
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational cross sectional study included 202 patients diagnosed to have COVID-19. The study was conducted at Zagazig University Isolation Hospitals from the period of March 2020 to June 2021. The study was approved by Zagazig University Ethics Committee (number 9229). A written informed consent was obtained from all participants.

Inclusion criteria:

The study includes laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted l during the period of the study.

The patients were classified into two groups, group A included mild/moderate cases, group B included severe/critical cases according to the following criteria.

Severity of COVID-19 was graded as follows: mild; mild clinical symptoms, no pneumonia on lung CT; moderate: fever, cough and lung CT with pneumonia; severe: respiratory distress (respiratory rate > 30 /min, oxygen saturation (O2Sat) ≤ 93 percent at rest and/or ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤300 mmHg (PaO2/FIO2); and critical: aforementioned criteria of respiratory failure receiving mechanical ventilation, shock, and/or organ failure other than lung and/or intensive care unit (ICU) hospitalization.

All participants were subjected to full history taking including smoking history and comorbidity profile. Clinical symptoms including: fever, cough, dyspnea, myalgia, hemoptysis, sore throat, diarrhea, loss of smell and anorexia were recorded. Radiological assessment by initial chest x ray then CT chest as possible and appropriate. Routine laboratory investigations: Complete blood count (CBC), coagulation profile, serum biochemical tests (including renal and liver function, and electrolytes), laboratory investigation to assess severity of COVID-19: lactate dehydrogenase (LDH), myocardial enzymes (CPK-MB), serum ferritin, D dimer and arterial blood gases analysis. Patients were followed up for the need for ICU and mechanical ventilation (MV), duration till conversion, total length of stay and final outcome whether survived or died were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted during the period of the study.

Exclusion Criteria:

• age less than 18

• refusal to participate

• referral to other hospital within 24 hours of admission

• missing data registry

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• routine laboratory tests
Complete blood count (CBC), coagulation profile, serum biochemical tests (including renal and liver function, and electrolytes), laboratory investigation to assess severity of COVID-19: lactate dehydrogenase (LDH), myocardial enzymes (CPK-MB), serum ferritin, D dimer and arterial blood gases analysis

Locations

Country	Name	City	State
Egypt	Zagazig University Faculty of medicine Chest Department	Zagazig	Asharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing severity of COVID-19	Severity of COVID-19 was graded as follows: (1) mild; mild clinical symptoms, no pneumonia on lung CT; (2) moderate: fever, cough and lung CT with pneumonia; (3) severe: respiratory distress (respiratory rate > 30 /min, oxygen saturation (O2Sat) = 93 percent at rest and/or ratio of arterial oxygen partial pressure to fractional inspired oxygen =300 mmHg (PaO2/FIO2); and (4) critical: aforementioned criteria of respiratory failure receiving mechanical ventilation, shock, and/or organ failure other than lung and/or intensive care unit (ICU) hospitalization [according to 16.National Health Commission of China. The novel coronavirus pneumonia diagnosis and treatment program, 7th version. China. 2020.http://www.nhc.gov.cn/yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml. Accesed 04 Apr.]	30 days from admission